A Single-Blind, Pilot Study to Determine the Tolerability and Safety of TD-1211 in Subjects With Opioid-Induced Constipation
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Glycyx Therapeutics
- Enrollment
- 95
- Locations
- 1
- Primary Endpoint
- Safety and tolerability of TD-1211
Study Overview
Brief Summary
A Single-Blind, Pilot Study to Determine the Tolerability and Safety of TD-1211 in Subjects with Opioid-Induced Constipation
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •stable dose of opioids for at least 12 weeks before screening visit
- •less than or equal to 5 spontaneous bowel movements for a 2 week period and experiencing at least one other symptom of constipation
- •willing to stop laxatives and other bowel treatments; rescue laxative allowed
Exclusion Criteria
- •Clinically significant condition or illness (other than the condition for which the pain medication was prescribed)
- •Have participated in another clinical trial of an investigational drug 30 days prior to screening
- •History of cancer treatment except adequately treated localized skin cancer within 5 years of screening
- •History of chronic constipation prior to opioid therapy
- •Females who are pregnant or breast feeding
- •Have any condition that may affect drug absorption (e.g. previous GI surgery)
Arms & Interventions
Cohort 6
2.5 mg TD-1211 every 6 hours for 14 days
Intervention: Placebo (Drug)
Cohort 5
2 mg TD-1211 once daily for 14 days
Intervention: TD-1211 (Drug)
Cohort 5
2 mg TD-1211 once daily for 14 days
Intervention: Placebo (Drug)
Cohort 3
5 mg TD-1211 once daily for 2 days followed by 10 mg for 14 days
Intervention: TD-1211 (Drug)
Cohort 2
5 mg TD-1211 once daily for 4 days followed by 15 mg for 14 days
Intervention: TD-1211 (Drug)
Cohort 6
2.5 mg TD-1211 every 6 hours for 14 days
Intervention: TD-1211 (Drug)
Cohort 4
5 mg TD-1211 once daily for 2 days followed by 15 mg for 14 days
Intervention: TD-1211 (Drug)
Cohort 1
5 mg TD-1211 once daily for 4 days followed by 10 mg for 14 days
Intervention: TD-1211 (Drug)
Outcomes
Primary Outcomes
Safety and tolerability of TD-1211
Time Frame: 14 days
Secondary Outcomes
- Complete spontaneous bowel movements (CSBM); Spontaneous bowel movements (SBM)(Weekly assessments throughout Treatment Period)